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| Shared decision making in parents of children with head trauma: Head CT (Computed Tomography) Choice | |
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| Investigator (PI): | Hess, Erik |
| Performing Organization (PO): | (Current): Mayo Clinic, Department of Health Sciences Research, Division of Health Care Policy and Research / (507) 284-2511 |
| Supporting Agency (SA): | Patient-Centered Outcomes Research Institute (PCORI) |
| Initial Year: | 2013 |
| Final Year: | 2017 |
| Record Source/Award ID: | PCORI/CE-12-11-4435 |
| Funding: | Total Award Amount: $1,679,700 |
| Award Type: | Contract |
| Award Information: | PCORI: More information and project results (when completed) |
| Number of Subjects: | 1004 |
| Abstract: | Background: In the United States, more than 650,000 children visit emergency departments (EDs) annually with "minor head trauma" (Glasgow Coma Scale scores of 14-15). Among these, up to 50% undergo head computed tomography (CT), though fewer than 10% have traumatic brain injury (TBI) on CT and only 0.1% requires surgical intervention. Over the past decade, use of CT for minor head trauma has more than tripled. Radiation from CT increases cancer risk, especially in children who are more radiosensitive than adults are. We derived and validated two clinical prediction rules (one for children under 2 years of age and one for those 2-18) for TBI in more than 42,000 children from 25 EDs in the Pediatric Emergency Care Applied Research Network (PECARN). The rules accurately quantify the risk of TBI in children with minor head trauma. We integrated these risk estimates into a decision aid, Head CT Choice, to assist parents of children with minor head trauma in making risk-informed decisions about whether to obtain a head CT or to actively observe their child after ED discharge. Head CT Choice communicates the risk of TBI and the future risk of cancer associated with radiation exposure, informs parents of the advantages and disadvantages of management options, and aligns parents' choice with values and preferences, thus promoting shared decision making and enhancing the quality of care. Objectives: Our long-term goal is to promote evidence-based, patient-centered evaluation in the acute setting to tailor testing more closely to disease risk. To, as PCORI specifies, "compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration," we propose the following aims. Aim 1 is to give parents a voice and incorporate the perspectives of multiple stakeholders by refining the Head CT Choice decision aid. Hypothesis: Engaging stakeholders in an evidence-based, iterative participatory action research process will produce a refined decision aid that is ready for testing. Aim 2 is to test if the decision aid improves validated patient-centered outcome measures and safely decreases health care utilization. Hypothesis: The intervention will significantly increase parents' knowledge, engagement, and satisfaction; decrease the rate of head CT; and decrease 30-day total health care utilization with no increase in adverse events. Methods: Patients and other PCOR stakeholders have been and will be engaged throughout the entire research process. We will refine the decision aid and test it in a pragmatic patient-level parallel randomized trial. Parents randomized to intervention will engage with their clinician in shared decision making, and parents randomized to control will receive usual care. Expected impact: If the effectiveness of Head CT Choice is demonstrated in multiple centers, it will dramatically improve the experience of care for millions of parents and children and safely decrease resource use. |
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| Country: | United States |
| State: | Minnesota |
| Zip Code: | 55905 |
| UI: | 20143213 |
| CTgovId: | NCT02063087 |
| Project Status: | Completed |
| Record History: | ('2017: Project extended to 2017.',) |